FDA Approvables
Just wanted to let my readers know that the PGS report describing recent FDA experience with approvable actions is now available for purchase at http://www.pharmagrowth.com/approvables.html. It’s the first report we’ve made available to the general public. The report covers in detail the approvables process and describes the impact an approvable decision has on eventual NDA/BLA approval. Importantly, the report also finds that certain FDA divisions are more (and less) likely than others to issue approvable actions and documents the issues most likely to result in approvability, and their impact on approval time. These data are essential to anyone responsible for contributing to US new drug approval or who depend on knowing the likely timing of US new drug approval. If you think about it, that just about all managers involved with new drug development and marketing. It’s important stuff, and it’s not available anywhere else.
